Unit dose packaging is an attractive packaging format that is used for a variety of applications. Examples of dose packaging include the well known blister package or blister card, the most common use being to contain articles such as, tablets, pills, capsules and similar consumable items. Conventional blister packages generally include a blister pack that typically comprises a thermo-formed plastic sheet containing integrally formed blisters that are dimensioned to hold one or more articles. Articles are disposed within each blister and the plastic sheet is sealed to a backing sheet that normally comprises a foil, plastic film, or paperboard barrier. The backing sheet is applied to cover each blister and securely houses the articles therein. To release an item from a blister, the backing sheet is punctured or ruptured. However these packages can be used for containing and carrying medical compositions in the forms of pills or tablets.
These packages can also be easily used for containing and carrying medical devices such as syringes, catheters or insulin pens. The conventional blister packages provide removal of the items from the blisters, but offer no or very little child resistance.
It has been a practice of the drug industry particularly where childrens' medications are employed to make them more palatable so that children can be induced to take them. In this connection, aspirin, vitamins, anti-biotics and other medications are prepared to taste like candy so that a child will freely take them. If such drugs or medications are packaged in containers which are readily opened when accessible to children then the danger of a child accidently taking an overdose of the packaged contents exists if such a container is within the reach of a child and adequate safety precautions are not followed.
The problem of accidental ingestion of tablets contained in bottles or other packaging containers which can be easily opened by children is presently of huge concern in the international community.
Thus, child resistance is a feature that is particularly desired for unit dose pharmaceutical and medical device packaging.
One of the problems facing today's parents is keeping medication or pills beyond the reach of their children. Children do not have the ability to recognize the risk involved in consuming non-prescription medication. Because of this fact there is an urgent need for a package from which pills are readily accessible to the adult, but not accessible to the child.
Press-through packs or “blister” packs are commonly used today to package units of medication or pills for oral ingestion. The press-through package is made up of a blister sheet, typically a clear, preformed polyvinyl chloride or polystyrene with flexible bubbles which form separate compartments or blisters for one or more pills; and a second rupturable backing sheet, like an aluminium foil or paper sheet, which has been attached to the blister sheet. The metal foil is attached by heat-sealing, solvent welding, gluing, or otherwise adhering the foil sheet to the blister sheet. A tablet is removed from a blister by pressing on the flexible blister which in turn forces the tablet against the foil, rupturing the foil, and ejecting the tablet.
It is sometimes desirable in making such a press-through package to include between the blister and backing sheets a rigid tray in which there are holes which coincide with the blisters in said blister sheet. The rigid tray is used to protect the pills from contamination and mechanical damage and may contain printed instructions as to the type of pill or the time a particular dosage is to be taken and with an indication of the dosage that has already been taken.
Measures taken to provide blister packages with child resistant features have generally included adding additional or thicker push-through films, applying stronger adhesion of peel films or tear-away strips, forming backings comprising heavier substrates. A downfall of the added safety features is that the blister package can be difficult to open by a user, is expensive and over packaged. For example, one result of added materials is that certain articles crumble when attempting to dispense the article from the reinforced backing sheet of the blister pack.
The recent trend in the packaging of medication has been to provide packages which will be safe, even if found by children. Most developments in the “child-resistant” line have been directed to the improvement in pill bottles. In this regard, safety caps have been devised which require a certain series of pushes and turns in order to open the bottle. However, there has been little development in the area of “child-resistant” press-type blister packages with which this invention is concerned.
All these so called safety packages have been found to be inadequate because where safety precautions are not taken a child could accidentally obtain sufficient quantities for an overdose.
In addition to a blister package being child resistant, it is desirable that the package permits easy withdrawal of items from the package by those intended to use the item stored therein such as an adult taking a prescription. As the blister packages are designed to be more resistant to tampering by a child, the elderly may have difficulty gaining access to the pharmaceutical dosage of medication within the package. This is especially important for users or patients whose manual dexterity and strength is reduced.
Accordingly, there remains in the art a need for a packaging system that is economical to manufacture and assemble, light weight, and provides child-resistant security features. There also remains a need for a packaging system that permits withdrawal of the item stored therein without the use of a tool, and with little manipulation of a user.
Hence, an improved medical package would be advantageous, and in particular a medical package with improved child safe features would be advantageous.